Shares of Relmada Therapeutics, Inc. (NASDAQ:RLMD) rose 25% on Monday after the company released 12-month interim data from its Phase 2 study testing NDV-01 in patients with high-risk non-muscle invasive bladder cancer (NMIBC).
The trial reported a 12-month complete response (CR) rate of 76% across the study population, while 95% of patients achieved a CR at any point during follow-up. In the subgroup identified as BCG-unresponsive, the 12-month CR rate was 80%, with 94% experiencing a CR at any time.
Relmada said no patients in the study progressed to muscle-invasive disease and none required radical cystectomy during the interim observation period. The company also reported no Grade 3 or higher treatment-related adverse events and no treatment-related discontinuations.
Of the 48 patients who received at least one dose of NDV-01, 30 (63%) experienced a treatment-related adverse event. The most commonly reported event was dysuria, occurring in 54% of treated patients. Asymptomatic positive urine culture and hematuria were each reported in 8% of patients.
Looking ahead, Relmada intends to move NDV-01 into the Phase 3 RESCUE registrational program in mid-2026. The company plans to pursue two development pathways within that registrational effort - second-line treatment for BCG-unresponsive NMIBC and adjuvant therapy in intermediate-risk NMIBC.
Relmada provided market estimates tied to those pathways, saying the intermediate-risk NMIBC population affects roughly 75,000 patients annually in the United States, and that BCG-unresponsive NMIBC with carcinoma in situ impacts about 5,000 patients per year.
In conjunction with the release, the company disclosed a private investment in public equity (PIPE) financing expected to generate gross proceeds of approximately $160.0 million. Relmada is offering 29,474,569 shares of common stock at $4.75 per share, and pre-funded warrants to purchase 4,210,527 shares at $4.749 per warrant. The financing is expected to close on or about March 11, 2026. Jefferies, Leerink Partners, Piper Sandler and Mizuho are serving as placement agents for the transaction.
Contextual note - The results and financing details above reflect the company's announced interim data and planned capital raise. The Phase 3 RESCUE program timing is described as mid-2026 and the PIPE closing is described as on or about March 11, 2026 in the company's disclosures.